Miscellaneous Gastrohepatic Disorders Archives - Page 3 of 21 - MPR

Miscellaneous Gastrohepatic Disorders

Priority Review Granted to Obeticholic Acid for Fibrosis Due to NASH

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for obeticholic acid (Intercept) for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH). The NDA submission includes data from the REGENERATE trial, a phase 3, double-blind, placebo-controlled study that evaluated the safety and efficacy of obeticholic acid in…

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FDA: Nitrosamine Impurity Identified in Commonly Used Acid Suppressant

According to the Food and Drug Administration (FDA), a nitrosamine impurity, N-nitrosodimethylamine (NDMA), has been identified in some samples of ranitidine. NDMA was one of several nitrosamine impurities implicated in the massive recall of angiotensin II receptor blockers (ARBs) since last year.  NDMA is classified as a probable human carcinogen; the impurity was identified following…

FDA Approves First-in-Class Treatment for IBS-C

The Food and Drug Administration (FDA) has approved Ibsrela (tenapanor; Ardelyx) for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Ibsrela is a locally-acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium.…